CompletedPhase 4

Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting

Austria, Germany100 participantsStarted 2009-09-01

Plain-language summary

This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine. The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 50
. 1 to 3 contiguous target vertebral compression fractures (VCF) meeting the following criteria:
. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1.x fractures and A3.1 fractures may be included in the study).
. All target VCFs are between Th5 and L5
. Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty
. No major surgery to the spine planned for at least 1 month following enrollment
. Pre-treatment back pain by numerical rating scale (NRS) score \>= 4 (0-10 scale)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Increase and maintenance of the vertebral body height

Timeframe: 12 months

Visual analog scale (VAS) for back pain

Timeframe: 12 months

Adverse events

Timeframe: 12 months

Trial details

NCT IDNCT01847898

SponsorSynthes GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-31

View on ClinicalTrials.gov More Vertebral Body Fractures trials

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 50
. 1 to 3 contiguous target vertebral compression fractures (VCF) meeting the following criteria:
. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1.x fractures and A3.1 fractures may be included in the study).
. All target VCFs are between Th5 and L5
. Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty
. No major surgery to the spine planned for at least 1 month following enrollment
. Pre-treatment back pain by numerical rating scale (NRS) score \>= 4 (0-10 scale)

Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria